MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE; POUCH, COLOSTOMY

Model Number 175783

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fluid Discharge (2686)

Event Date 01/25/2015

Event Type  Injury  

Event Description

The end user reported that she developed a red weeping area under the adhesive barrier that extended downward to end of pouch.She was advised to see her physician, which she did and was prescribed nystatin.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Note: this issue occurred on (2) separate cases.A separate 3500a form has been completed for the other (1) case.

• Brand Name: ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4584644
• MDR Text Key: 20152864
• Report Number: 1049092-2015-00143
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FAMOTIDINE; PRAMIPEXOLE; ASPIRIN LEVOTHYROXINE; BACLOFEN; HYDROCODONE; GABAPENTIN; CELECOXIB; LISINOPRIL; DULOXETINE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 95